WO2021180682A1

WO2021180682A1 - A device for treatment of obesity or diabetes of a patient and a method for selecting such a device

Info

Publication number: WO2021180682A1
Application number: PCT/EP2021/055850
Authority: WO
Inventors: Thierry MANOS; Christophe Bastid; Philippe Pouletty; Marco Gard; Éric SÉJOR; Youssef Biadillah
Original assignee: Bariatek Medical
Priority date: 2020-03-09
Filing date: 2021-03-09
Publication date: 2021-09-16
Also published as: CN115715176A; JP2023517645A; EP4117588A1; EP3878415A1; AU2021233124A1; BR112022017931A2; CA3170879A1; US20230107981A1

Abstract

A device (10) for treatment of obesity or diabetes comprises a duodenal tube (12), first anchor (14) arranged at a pre-defined distance (D) from a proximal end (15) of the duodenal tube (12). The first anchor (14) is adapted for anchoring the tube (12) distally to the pylorus (P) without mucosal involvement. A second anchor (17) in the form of a conical, inflatable balloon is used for anchoring the device (10) in the stomach (S) of the patient. The duodenal tube (12) is flexible and can be arranged in the duodenum (D) and in the jejunum (J) of the patient.

Description

A device for treatment of obesity or diabetes of a patient and a method for selecting such a device

Field of the Invention

The invention is directed to a device for the treatment of obe sity or diabetes of a patient and to a method for selecting such a device.

Background to the Invention

It is known in the prior art to use implantable devices for the treatment of obesity which bypass a certain length of the duode num. Typically such devices may be delivered in a minimally in vasive manner and are anchored at one or more positions.

US 2018/0214293 discloses the anchoring of a device on the pylo rus with stents or alternatively by using an inflatable balloon. A similar anchoring is disclosed in US 9,421,116.

WO 2014/195954 discloses a device with several anchors. First and second anchors comprise stents and are pushed against the walls of parts of the duodenum. An additional, intragastric an chor for deployment within the stomach of the patient is dis closed. WO 2012/087669 also discloses intragastric anchors.

US 2005/273060 discloses the anchoring of a device on the pylo rus with balloons which also reduce the volume of the stomach.

US 5,820,584 also discloses the anchoring of a device on both sides of the pylorus. The anchoring of a device for treatment of obesity and diabetes on the pylorus by means of inflatable an chors is also disclosed in US 2011/0004320. US 2017/312112 discloses a transpyloric device for accepting chyme from the stomach and conducting said chyme in a bypass like manner through a patients duodenum. The device is held in place by balloon segments which sit on a transpyloric conducting element .

The devices according to the prior art do all have certain dis advantages. In particular, they may be difficult to deploy and/or anchor, they may create an undesirable mucosal engagement and they may have unreliable anchoring.

Summary of the Invention

It is an object of the present invention to overcome the draw backs of the prior art, in particular to provide a device for treatment of obesity or diabetes which is easy to manufacture, easy to deploy, which offers a reliable anchoring and which does not have negative side effects, in particular due to mucosal en gagement. A further object of the invention is to provide a method which allows to improve the treatment of the patient.

According to the present invention, these and other objects are solved with a device and a method according to the independent claims.

According to the invention, a device for treatment of obesity or diabetes is provided. Typically, with some minor modifications, the same principle of a device can be used for both, the treat ment of obesity and the treatment of diabetes. The device com prises a duodenal tube. This tube is adapted to be placed in the duodenum and optionally in the jejunum or also in the ileum of a patient. A first anchor is arranged at a pre-defined distance from a proximal end of the duodenal tube. This first anchor is preferably adapted for anchoring the tube distally to the pylo rus without substantial mucosal involvement, in particular with out mucosal penetration. In this context, without substantial mucosal involvement means that even though the mucosa may occa sionally or temporarily be contacted by the first anchor, an choring of the device is not based on a contact, engagement or penetration of the mucosa, for example, by the anchor. More par ticularly, the anchor is formed and/or configured in such a way that it does not continuously and tightly contact the mucosa. By providing such an anchor, irritations of the mucosa may be avoided. Typically, the first anchor is designed such as to pro vide a certain weight which will create a positioning and an choring due to peristatic effects. Since anchoring is not due to frictional engagement, the size and shape of the first anchor may be chosen such as to avoid mucosal engagement. Additionally or alternatively, another way of avoiding substantial mucosal involvement is to provide a buffer material, for example a flex ible cover, around at least part of the anchor. In use, the buffer material, where used, may separate the anchor from direct contact, engagement or penetration of the mucosa. The buffer material may provide a smoother or more atraumatic tissue-facing surface than the surface of the anchor alone. The buffer materi al may, for example, be of different material from the first an chor. Additionally or alternatively, the buffer material may, for example, be of or comprise one or more of: polyurethane; silicone; pericardial tissue or other biological material; da cron; polytetrafluoroethylene.

In a preferred embodiment the first anchor may comprise or may be formed of an expandable structure. Typically, self-expandable structures are known in the art for providing stents. The self- expandable structure can be made of a metal, preferably of a shape memory metal such as Nitinol. Shape-memory plastics may also be used. The self-expandable structure preferably can be braided. Other embodiments such as embodiments using self- expandable structures which are cut from a tube are also con ceivable. It is also possible to use balloon expandable struc tures or structures which are self-expandable to a certain ex tent, but need balloon support for a complete expansion. Other biocompatible materials such as other metals, alloys or biocom patible plastic materials are possible. In some embodiments, the expandable structure (e.g. self-expandable structure) is tubular and/or is elongate in an axial direction of the duodenal tube.

The expandable structure may be covered by one or more layer of a covering material, in particular a polymeric layer including or made of Dacron or a biologic layer, such as pericardial tis sue. The layer may be a foil of a plastic material. It may also be a woven or knitted structure of polymeric filaments. The cov ering material may act as a buffer between the expandable struc ture and the mucosa to avoid substantial mucosal involvement be tween the anchor and the tissue, whatever the shape of the ex pandable structure.

The first anchor and in particular the first expandable struc ture may be retrievable and repositionable. A retrievable struc ture may be brought back into a narrower and typically into the initial configuration, allowing removal of the structure and of the entire device from the patient's body. This allows easy re moval of the device, e.g. in case of unexpected side effects.

The structure and hence the device also can be repositionable, i.e. allowing reduction of the size allowing to displace the de vice at the application site, followed by another expansion for anchoring at another site. Any mechanism for bringing the structure and the device into a narrower configuration may be possible: Interior engagement mem bers may allow engagement with an internal tool for crimping from the inside. Deactivation of a support structure such as an inflated balloon may lead to a collapse of an expanded structure in case the structure was expanded against a radial force, e.g. an elastic deformation. It is also conceivable to use thermal or chemical mechanisms for bringing the structure back to the nar rower configuration.

It is also conceivable to additionally or alternatively anchor the duodenal tube by means of patches which are attachable to the mucosa and which are linked to the duodenal tube through connections, e.g. threads, fibres or wires. The patch preferably comprises a biocompatible adhesive. It alternatively or addi tionally may be adapted to promote cell biocolonization. The patches also can be biodegradeable. Such patches may help to further anchor the device, without having, however, any traumat ic effect on the mucosa.

The layers and/or the patches may be formed such as to avoid en dothelialisation .

According to a particularly preferred embodiment of the inven tion, the duodenal tube may be provided with a second anchor which is arranged at its proximal end. The second anchor is adapted to be positioned proximally of the pylorus for anchoring the device in the stomach. Optionally, the size and/or the shape and/or configuration of this second anchor may be chosen such as to avoid mucosal engagement. The second anchor may be formed as, or comprise, a balloon (e.g. an inflatable balloon) which is adapted to be positioned within the patient's stomach such as to reduce the gastric functional volume. The balloon may be shaped and/or sized and/or configured such as to avoid a tight contact with the inner wall of the stomach when it is appropriately inflated.

As used herein, the term "balloon" is intended to cover any flexible bladder or pouch that can sealingly envelope a certain quantity of fluid, such as gas (e.g. air or nitrogen) or liquid (e.g. saline). The term "inflatable" and the like refers to the balloon being at least partly tillable with fluid to at least partly distend the balloon, whether the balloon is filled com pletely to capacity or only partly filled. In some embodiments, only partly filling (or partly inflating) the balloon may be a manner of configuring the balloon to avoid substantial mucosal involvement. A partly filled balloon may be more flexible and conformable against the stomach wall when subjected to stomach muscle contractions, than a balloon that is fully distended by filling to capacity (or inflating to capacity).

In a first variant, the balloon may have an annular shape sur rounding the duodenal tube. Thereby, a homogenous anchoring may be achieved. Furthermore, a regular, annular shape which com pletely surrounds the duodenal tube may lead to regular closure pattern of the passage into the duodenum.

In a first variant, the balloon may have a crown shape when it is inflated.

In a particularly preferred variant, the balloon may have a to roidal shape. According to another variant, the balloon may have, in the in flated condition, a specific shape and size in an area neigh bouring the connection to the duodenal tube: the inflated bal loon may e.g. have a conical outer shape or a concave outer shape in a cross-section through a plane running through an axis of the device. The balloon may also have a tulip shape. These shapes combine a reliable anchoring and avoid a distal migration of the device without, however, continuously requiring an en gagement of the anchor with tissue and in particular mucosal en gagement .

According to another variant, the second anchor may comprise one or more balloons defining plural chambers or bodies. The bodies may be independently inflatable, or they may be interconnected to be in fluid communication with one another. The bodies may optionally be defined by respective plural balloons and/or by at least a first balloon segmented or partitioned into plural bod ies. The bodies may have one of more shapes selected from spher ical, and/or tear-drop, and/or any other desired form. The bod ies may nestle together to define collectively a voluminous bulb, e.g. with a tulip shape, but with a fluted or lobed exte rior profile presenting a smaller tissue-contacting extremity than would a smooth bulbous single body. The spaces between and around adjacent bodies also help to keep open natural passages to allow chyme to enter the duodenal tube, and avoid trapping of chyme outside the duodenal tube at the antrum.

By using a conical, concave or tulip shape, and/or by using one or more balloons defining plural bodies, it is possible to place the device closer to the pylorus without the risk of contacting tissue. Typically, the balloon and/or collectively the multiple bodies if used, may be adapted to be inflated to a volume of between 200 ml to 800 ml, more preferably to 300 ml to 450 ml.

While it is understood that such kind of second anchors are par ticularly preferred in combination with a device with a first anchor as described herein above, the skilled person will appre ciate that such second anchor also can be used without such first anchor or with a differently shaped first anchor.

The second anchor additionally or alternatively may comprise a second expandable, in particular self-expandable structure. Such a device in particular may decrease the absorption of sugars and lipids and may be particularly suitable for treatment of diabe tes.

The second anchor may have an at least partial hour-glass shape so that, preferably together with the first anchor, there may be an hour-glass like shape for anchoring on both sides of the py lorus. The hour glass shape may be symmetric or asymmetric, for example, with respect to a shape on either side of the pylorus, and/or with respect to a shape around the longitudinal axis of the tube.

Also this expandable structure may be made of a metal, prefera bly a shape memory metal such as Nitinol. Also the second ex pandable structure may be braided or alternatively laser-cut from a metallic tube. The second expandable structure also may be covered by one or more layers, in particular a polymeric lay er including or made of Dacron or polyurethane or a biologic layer, such as pericardial tissue. The layer may be a foil of a plastic material. It may also be a woven or knitted structure of polymeric filaments. The layer may act as a buffer to avoid sub- stantial mucosal involvement between the expandable structure and the stomach tissue.

The self-expandable structure of the second anchor may include at least a tubular portion. In some forms, the self-expandable structure flares outwardly in a direction away from the distal end of the duodenal tube. The flared shape may, for example, be conical or at least partly curved (e.g. curvilinear). The flared shape may, for example, resemble any of a tulip, an umbrella, a dish, or a trumpet mouth. The flared portion may, for example, comprise a plurality of arms or ribs extending from a hub. Al ternatively, the flared shape may comprise a lattice structure or a braid.

In some embodiments, the second anchor may comprise both a self- expandable structure and at least one balloon. The self- expandable structure may optionally be attached to the balloon. The self-expandable structure may be arranged outside the bal loon, or in a fluid chamber of the balloon, or in an open space around which the balloon is disposed, or in a wall of the bal loon. The self-expandable structure may extend circumferentially around a portion of the duodenal tube adjacent to or at the proximal end of the duodenal tube.

The self-expandable structure may serve to hold open the duode nal tube and/or a passage within the balloon, for the evacuation of stomach contents, and resist any tendency for the tube or the passage to be permanently crushed or constricted under the in flation pressure exerted by the surrounding balloon. The self- expandable structure may also deform temporarily in response to stomach contraction forces, but return towards its expanded state when the stomach contraction relaxes. Additionally or al ternatively, the self-expandable structure may serve to bias the balloon towards a predetermined expanded shape before and/or af ter inflation of the balloon.

The self-expandable structure and the balloon may be generally co-extensive at least in one axial direction with respect to an axis of the duodenal tube, optionally in both axial directions. Additionally or alternatively, one of the self-expandable struc ture and the balloon may extend proximally of or proximally be yond the other. For example, the balloon may extend proximally beyond an end of the self-expandable structure and/or proximally beyond a proximal end of the duodenal tube.

Optionally, only one of the two anchors comprises both a self- expandable structure and a balloon. This can reduce the amount of superimposed material necessary to fold and/or compress to a compressed state for introduction. The other anchor may com prise selectively only an expandable structure (e.g. a self- expandable structure) or a balloon.

For example, in some embodiments, only the second anchor com prises the combination of a self-expandable structure and a bal loon. There is more space for such an anchor in the stomach, than in the duodenum. Also, since the need for fluid inflation adds complexity to the delivery system, for example with a fluid inflation conduit and removable connection, including these fea tures on only the stomach side, avoids over-complicating the de livery system, particularly in the region of the duodenum where there is less space. It also simplifies the procedure for in troducing and installing the duodenal tube in a patient.

In a similar way as described in context with the first anchor, also the second anchor may be retrievable and/or repositionable. The second anchor may also comprise patches, similar as de scribed above in context with the first anchor.

According to a preferred embodiment of the invention, the device may be provided with at least one element on the duodenal tube in addition to the anchors. Such element may have several pur poses. It can be used for imaging if it is of metal or other ra diopaque material and provides a higher contrast in e.g. x-ray imaging or in a CT scan. If made from metal or other materials with a high specific weight, it can also be used for additional ly anchoring the device due to its weight.

In one embodiment the at least one element is metallic and can be formed as a ring which is mounted on the surface of the duo denal tube. Typically, the ring can be mounted at the distal end of the duodenal tube. Additionally or alternatively it can also be mounted in an area of the duodenal tube which is distant from the distal end. Typically, it can be arranged at a distance of 8 to 12cm from the distal end of the duodenal tube.

Additionally or alternatively to any of the above, the duodenal tube may comprise reinforcement for resisting any tendency of the duodenal tube to twist, at least in one or more local re gions. Twisting of the tube can create kinks that might narrow the tube and, in severe cases, completely block the tube itself to all passage of stomach contents through the twisted region.

In one variant, reinforcement of the duodenal tube may be pro vided between the first and second anchors. The reinforcement may, for example, comprise structure, struts or filaments in or on the tube, optionally extending from one or both anchors. Ad ditionally or alternatively, reinforcement may be provided in a portion of the tube that is distal to the first anchor. The re inforcement may again comprise structure, struts or filaments in or on the tube, optionally extending in a spiral along an axis of the tube. In either case, some of the structure, struts or filaments may extend in a direction that is at least partly axi al, to buttress the tube against twisting. The structure, struts or filaments may be of metal, for example, nitinol or stainless steel, or of plastics, for example, PET or polyure thane or polytetrafluorethylene.

According to still another embodiment of the invention, the duo denal tube may be adapted to be shortened for adaptation to at least one characteristic of the patient. For this purpose, the tube in particular can be provided with markings which indicate a certain length and/or with weakening zones which facilitate shortening. Depending on certain characteristics of the patient to be treated, shorter or longer tubes may be selected for im plantation. The characteristics typically may be the thickness of abdominal fat panicle, the fat mass surrounding the abdominal cavity, the visceral fat mass or the fat inside and/or outside the abdominal cavity. Computerized Tomography may be used in a non-invasive, objective and easy to repeat evaluation. Other characteristics may be the body surface area, the body mass in dex or the abdominal perimeter. By providing such an adaptation, an optimal treatment may be achieved. In particular, the amount of the effect created by the bypass may be individually chosen.

According to another preferred embodiment of the invention, the device can be activatable in dependence of a contact with the content of the stomach and or intestine. For this purpose, at least one of the duodenal tube, the first and the second anchor may be activated, e.g. expanded, if brought in contact with body fluid or nutrients. In particular, the duodenal tube may be di lated in response to a contact with contents of the stomach or intestine. In particular, the device hence may only become di lated if needed, i.e. if the stomach or intestine is filled.

Typically, the first anchor has an axial length of 1 to 10 cm, optionally 1 to 3 cm. Typically, the second anchor has an axial length of 2 to 10 cm.

The duodenal tube may have a length in the range of 300 to 800 mm, preferably 400 to 700 mm. It may have a diameter in the range of 20 to 35 mm. In a particularly preferred embodiment, the tube has a length of about 600 mm and a diameter of about 28 mm.

Preferably, the duodenal tube is made of a material which avoids a contact of nutrients migrating within the tube with the duode nal wall. Typically, the duodenal tube may be made of polyure thane. Any other material having a suitable anti-migrating ef fect on nutrients may be used. Furthermore it is possible to se lect a material for the duodenal tube which is reactive to the content of the stomach or intestine: In particular the material of the duodenal tube may have an osmotic permeability for spe cific nutrients which may decrease the higher the content of the nutrients is. It is also possible to choose a material which se lectively reduces the retention or absorption of certain con stituents within the duodenum. The material may e.g. be selec tively permeable for fats, proteins or sugars, depending on the desired treatment.

According to another preferred embodiment, the duodenal tube may include sensors and/or actors (e.g. actuators) for actively mod ifying the structure and/or the shape and/or the size of the du odenal tube in reaction to changing conditions. In particular, there may be actor on the device which modifies the shape of the tube in answer to the amount or type of bodily fluids measured by the sensors. For this purpose, the device may include elec tronics for treatment of signals provided by the sensors and for controlling an actuator, e.g. voltages influencing the structure of the material of the duodenal tube or driving members for changing the shape or the size such as e.g. piezo electric ele ments.

Another aspect of the invention provides a device (for example, a duodenal tube optionally having any of the features discussed above) for installation in the gastrointestinal tract of a pa tient for the treatment of obesity or diabetes, the device hav ing one or more sensors, for example one or more biosensors, which provide information, e.g. relating to such as the content of nutrients or the status, shape or size of the device. Such information may be used within the device in a closed loop feed back and/or may be transmitted externally, e.g. via wireless communications for subsequent use by a care person. In particu lar, it may be possible to selectively change the size and shape of the device in answer to the amount of nutrients measured in the stomach and/or in the intestine. In particular, in case of a higher amount of nutrients, the volume occupied by the device and/or the surface of the stomach and/or the intestine covered by the device may be increased.

In some embodiments, the sensor may be a pressure sensor for measuring inflation pressure within a balloon. The balloon may, for example, be a balloon of one or both anchors of a duodenal tube as discussed above. Additionally or alternatively, the balloon may be a balloon that is installed in the stomach. The measured pressure may be transmitted externally to an external monitor or display (for example, a wrist-worn or hand-held port able electronic device). Transmission of data between the device and an external monitor may be via any wired or wireless communication path, such as a near-field wireless communication technique that also enables power to be transmitted to the sensor, for example, by means of an inductive coupling or a radio-frequency communication cou pling.

While it is understood that specific adaptive or selective mate rials or mechanisms or sensors for the device and in particular the duodenal tube are particularly advantageous in context with a device with anchors as described herein above, it is under stood that such materials or mechanisms can be used in context with any other implantable device for treatment of obesity or diabetes, installable in the gastrointestinal tract. The device may optionally be adapted to be placed in the stomach and/or may have a duodenal tube adapted to be placed in the duodenum and optionally in the jejunum or ileum of a patient.

Another aspect of the invention is directed to a method for se lecting a device for treatment of obesity or diabetes of a pa tient. In particular, the method is used for selecting a device as it has been described herein above.

In a first step at least one characteristic of the patient is determined. This characteristic may be the thickness of the ab dominal fat panicle, the fat mass surrounding the abdominal cav ity, the visceral fat mass or the fat inside and/or outside the abdominal cavity. The characteristic may also be the body sur face are, the body mass index or the abdominal perimeter, meas ured on a standing patient at the umbilicus. The characteristic further may be the elasticity of the stomach, an index of elas ticity of the stomach or evaluation tests of absorption of nu- trients. By way of this, the patient specific absorption e.g. of fats may be taken into consideration. Of course, several of the se characteristics can also be used in combination with each other.

On the basis of the selected characteristic or characteristics, an appropriate length of the duodenal tube is then defined.

In a final step, a device with a duodenal tube having the de fined length is provided. This can be done by either shortening of the duodenal tube to the defined length or by selecting a de vice having a duodenal tube with the defined length. Such selec tion may be made either by selecting the device out of a set of devices having a various lengths or by individually manufactur ing a device having the selected length.

Alternatively or additionally to the step of defining the length of a duodenal tube, the filling volume of a gastric anchoring balloon may be defined based on the determined characteristic or characteristics .

According to a preferred embodiment of the invention, the fat inside and/or outside the abdominal cavity may be determined by computerised Tomodensitometry.

This method provides for an individualised and optimised device for treatment specifically for the individual patient.

Additionally or alternatively to any of the above, one aspect of the invention provides a device for treatment of obesity or dia betes. The device comprises a duodenal tube. This tube is adapted to be placed in the duodenum and optionally in the jeju num or also in the ileum of a patient. A first anchor is ar- ranged on the duodenal tube, optionally at a pre-defined dis tance from a proximal end of the duodenal tube. This first an chor is adapted for anchoring the tube distally to the pylorus (for example, without substantial mucosal involvement). A se cond anchor is arranged at and/or coupled to a proximal end of the tube (for example, without substantial mucosal involvement). Each of the first and second anchors may comprise a self- expandable structure, for example, made of shape-memory materi al, optionally a shape-memory metal, optionally nitinol. Only one of the first and second anchors, optionally the second an chor, additionally comprises a balloon, for example, an inflata ble balloon.

Brief Description of the Drawings

The invention will now be described with reference to certain embodiments and the accompanying drawings which show:

Figure 1: A schematic representation of a first embodiment of the invention

Figure 2: A schematic representation of a second embodiment of the invention

Figure 3: A representation of a third embodiment of the inven tion

Figure 4: The device according to figure 3 deployed within a patient

Figure 5: A schematic representation of a fourth embodiment of the invention Figure 6: The device of figure 5 deployed in a patient

Figure 7: A flow-chart showing the steps of a method according to the invention

Figure 8: A schematic representation of a fifth embodiment of the invention

Figure 9: CT images for evaluation of the abdominal fat.

Figure 10: A schematic representation of a sixth embodiment of the invention, showing principally the anchors when in situ

Figure 11: A schematic representation of a seventh embodiment of the invention, showing principally the anchors when in situ

Figure 12: A schematic representation of an eighth embodiment of the invention in situ

Figure 13: A schematic representation of a ninth embodiment of the invention in situ

Figure 14: A schematic representation of a tenth embodiment of the invention in situ

Figure 15: A schematic perspective view of the device from in Fig. 14, shown in isolation

Figures 16A-G: Schematic representations of a technique for de ploying the device in a patient's gastrointestinal tract Figure 17: A schematic representation of an eleventh embodiment of the invention, and

Figure 18: A schematic representation of an electronic system for monitoring the status of the device.

Detailed Description of Preferred Embodiments

In the following description, the same reference numerals, where used, denote similar or corresponding features, whether or not described explicitly. The disclosure of one embodiment is thus to be read in combination for another embodiment. Different ref erence numerals may also be used to denote similar or corre sponding features where this helps the description.

Figure 1 discloses a first embodiment of a device 10 which is used for treating a patient suffering from obesity. The device 10 is primarily formed by a duodenal tube 12 which has a second anchor 17 attached to its proximal end 15. Arranged at a dis tance d from the proximal end 15 there is a first anchor 14. The first anchor 14 is formed as a mass which has a tendency to move the duodenal tube 12 distally within the duodenum. This movement can be caused by peristaltic and/or gravitational effects. Se cond anchor 17 avoids a too far distal migration of the device 10.

The second anchor 17 is formed in the shape of a torus and sur rounds the perimeter of the duodenal tube 12 neighbouring its proximal end 15. An entry opening 18 is arranged in the toroidal second anchor 18. Nutrients may enter the interior of the duode nal tube 12 from the stomach through the opening 18, as indicat ed with an arrow in figure 1. The nutrients then quit the duode nal tube 12 at its distal end 20, again indicated by an arrow. Thereby, a certain distance of the duodenum is bypassed and nu trients are prevented from contacting the wall of the duodenum.

In the present embodiment, the duodenal tube has a length of 600 mm and a diameter of 28 mm and is integrally formed with the balloon-like second anchor 17. It is formed of polyurethane. The mass 14 preferably is formed of a self-expandable, braided structure of wires of a shape memory material. The second anchor 17 comprises an entry opening (not shown) which is connectable with a device for inflation which allows to inflate the balloon to an appropriate volume and size, typically to a volume of 350 ml.

Figure 2 shows an alternative embodiment of the second anchor 17. In difference to the embodiment of figure 2, the second an chor 17 is not formed as a torous, but rather has a tulip shape, i.e. a shape which, in a cross-section through a plane running through an axis of the device is slightly convex.

In the embodiment shown in figure 2, the first anchor 14 is de signed as a self-expandable structure made of braided nitinol wires. An additional support structure 22 is disclosed which helps to stabilize the device and/or anchor the device.

Figure 3 shows a more specific embodiment of a device 10 for treating a patient with obesity. The device is partly similar to the device of figure 1, with the following differences: the first anchor 14 is formed as a self-expandable structure made of braided nitinol. The embodiment of figure 3 is formed of the du odenal tube 12 made of polyurethane and of the inflatable second anchor 17. The second anchor 17 is attached to the duodenal tube 2 by gluing and is made of silicon. The second anchor 17 may have a toroidal, conical or tulip shape. The second anchor 17 has an axial length 11 of about 50mm, an internal diameter dl of the opening 18 of about 28mm and an external diameter d2 of about 50mm. The lips of the second anchor 17 typically may have a radial length r of 10 to 25 mm. By appropriately selecting the size, thickness and/or material of the duodenal tube 12, it can be made sure that the tube is sufficiently flexible such as to adopt its shape to the shape of the duodenum D and optionally the jejunum J.

The device 10 deployed within the patient is shown in figure 4. The device is anchored proximately of the pylorus P by means of the second anchor 17 whereas it is anchored distally of the py lorus P by means of the first anchor 14. The second anchor 17 has a conical or tulip-like shape which avoids contact with the mucosal wall of the stomach S. The second anchor 17 has a double function. On the one hand it reduces the volume of the stomach for reducing the feeling of hunger of the patient. Additionally, it avoids migration of the device into the distal direction. Due to the conical or tulip shape, a permanent contact with the mu cosal wall is, however, avoided. The second anchor 17 may freely float within the stomach. The first anchor 14 is also sized and shaped such that mucosal contact can be avoided. It is made suf ficiently short, typically with a length of 10 mm to 25 mm and covered by a layer of, for example, a buffer material, made of a biocompatible material such as Dacron and having a thickness of 0,7mm to 2 mm, which is not shown in detail in figures 3 and 4.

In addition, in the embodiment shown in figure 3, the duodenal tube 12 is provided with a ring 19 of a radio opaque material, in particular a metal. The ring 19 is arranged in an area 21 of the duodenal tube 12 which is distant from the proximal end 20 of the duodenal tube 12. This helps positioning the device under x-ray control. Figure 5 shows an embodiment of the invention which is suitable for treatment of diabetic patients. The device 30 according to figure 5 also comprises a duodenal tube 32. The duodenal tube 32 is provided with a first anchor 34 and a second anchor 37. The second anchor 37 is arranged neighbouring the proximal end 35 of the duodenal tube 32 whereas the first anchor 34 is arranged at a distance d of the proximal end 35. The first anchor 34 and the second anchor 37 both are formed of expandable structures 36, 38 of braided nitinol wire, respectively.

The duodenal tube 32 is provided with two rings on its outer surface: a first ring 39a is arranged at the distal end 40 whereas a second ring 39b is arranged in an area 41 which is distant from the distal end 40. Similar as in the embodiment of figure 3, the duodenal tube 32 of figure 5 is made of polyure thane. The anchors 34, 37 and the rings 39a, 39b are mounted on the duodenal tube by gluing. It is, however, also conceivable to integrate in particular the rings 39a, 39b between multiple lay ers of the duodenal tube.

In the embodiment shown in figure 5, the second ring 39 is typi cally arranged at the distance of 10cm from the distal end 40.

Figure 6 shows the device 30 of figure 5 deployed within a pa tient. The first and second anchors 34, 37 are arranged on both sides of the pylorus and prevent distal or proximal migration of the device while still avoiding a direct contact with the tissue of the involved stomach S or the duodenum D. The anchor 37 is substantially smaller that the anchor 17 of the embodiment of Figures 3 and 4, making the device 30 of Figs. 5 and 6 less suitable for treatment of obesity, but suitable for diabetes treatment. Figure 7 schematically shows various steps for selecting a de vice which is appropriate for an individual patient. In a first step "image" the patient is examined with examination methods known to the skilled person, in particular by diagnostic imag ing. Based on this examination or imaging step, certain charac teristics of the patient are then determined in step "Determine characteristic". Based on a CT scan, the thickness of the ab dominal fat panicle, the fat mass surrounding the abdominal cav ity and the visceral fat mass is determined. In addition, the body surface area, the body mass index and the abdominal perime ter are clinically defined. Additionally, it is also possible to define by way of CT scan the fat inside and/or outside the ab dominal cavity. Based on these six or seven objective criteria, the length of the duodenal tube is defined in step "Define length". The length is typically between 450 and 600mm. As a general rule and by way of example, for more severe conditions of obesity, longer tubes will be chosen.

The first three criteria easily can be determined manually on the basis of an image shown on a display screen of a CT scanner based on a cross-section along the third lumbar vertebra. Of course these criteria also can be assessed fully or partly auto matically by using artificial intelligent software.

In a final step "Shorten Tube", the tube is shortened to the de fined length. Shortening made be made by cutting. For that pur pose, markings may be provided on the outer surface of the duo denal tube (not specifically shown in figure 3). A ruler can be associated to the device. Alternatively to the step of shortening the tube, a tube with an appropriate length may be chosen from a set of standard dimen sions or may be individually manufactured.

Additionally or alternatively to the step of defining the length, also the inflation volume of the balloon like second an chor 17 may be determined based on the characteristic(s). By in flating the balloon to different volumes, an additional adapta tion to an individual patient is possible. The amount to which the stomach should be filled and the size of the second anchor thereby may be defined.

Fig. 8 shows another embodiment of a device 10 similar to the one shown in Fig. 1. In the embodiment of Fig. 8, the first and the second anchor are formed by inflatable balloons 14, 17.

Fig. 9 shows two CT images. The abdominal fat is evaluated using the CT images and variations of the grey scale.

Figs. 10 to 17 show further embodiments of a device 10 similar to the preceding embodiments. The embodiments of Figs. 10 to 17 are similar to one another in that the device 10 comprises a first anchor 14 mounted on the duodenal tube 12. The first an chor comprises a self-expandable structure, optionally in the form of a stent-like structure made of braided wires. The first anchor 14 may be made of shape memory material, for example, ni- tinol. The first anchor 14 can be covered with a buffer materi al 50, for example, of polyurethane. The configuration of the first anchor 14 and/or the provision of the buffer material can avoid substantial mucosal involvement between the first anchor

14 and the duodenal mucosa. For example, as can be seen in Fig. 10, the first anchor 14 is dimensioned to bridge the duodenal bulb DB without substantial mucosal involvement. The first anchor 14 may have a length of between about 50mm and 100mm, for example, about 80mm. The first anchor 14 may have a diameter (for example, between about 20mm and 40mm, for example about 25mm or 30mm) such that the first anchor 14 resists any tendency for the duodenal tube to shift proximally through the pylorus towards the stomach S. The first anchor 14 may include a distal shoulder (for example, of about 40mm in diameter) to provide an additional stop.

The embodiments of Figs. 10 to 17 differ from one another in the implementation of the second anchor 17. In the embodiment of Fig. 10, the second anchor 17 comprises a self-expanding struc ture 52, similar to Fig. 6. However, in Fig. 10, the self expanding structure has a shape like a trumpet mouth, with a proximal end forming a flange 54. The self-expanding structure 52 may have a braided or lattice structure made of a shape- memory material for example, nitinol. The self-expanding struc ture is covered with a buffer material 50, for example, silicone or polyurethane.

As can be seen in Fig. 10, the second anchor 17 closes off the antrum A of the stomach. The proximal flange 54 engages the stomach wall, and defines a closed-off space behind the flange, thereby reducing the volume of the stomach available for receiv ing food.

In the embodiment of Fig. 11, the second anchor 17 comprises a flared shape defined by a plurality of diverging ribs or fingers 56. The fingers 56 diverge in a direction away from the distal end of the tube 12, and extend from a collar 58 at the proximal end of the tube 12. The second anchor 17 may be covered by a buffer material 50, as described above with reference to Fig.

10.

In the embodiment of Figs. 12 to 17, the second anchor 17 com prises a self-expandable structure 52 and a balloon 60, for ex ample, an inflatable balloon. Various implementations are envis aged. Where a self-expandable structure 52 and balloon 60 are used together, it is optionally preferred that this be for only one of the anchors, in the illustrated embodiments, the second anchor 17. The combination of both structures increases the amount of material used at the anchor, and may have some effect on the size to which the anchor can be collapsed or compressed for delivery. Employing the combination of structures at one anchor can help limit the impact on size compared to using such a combination for both anchors. Employing the combination of structures specifically for the second anchor 17 may be appro priate for the anatomy, because there is more space available in the stomach than in the duodenum. There may also be a greater need for anchoring from the stomach side (to resist displacement towards the intestine) than from the duodenum side (to resist displacement towards the stomach), because the natural flow of chyme, and the majority of muscular movement, is from the stom ach side.

In Fig. 12, the self-expanding structure 52 has a flared shape, diverging outwardly in a direction away from the distal end of the tube 12. The self-expanding structure may comprise a braid or lattice of shape memory material, for example, of nitinol.

The self-expanding structure 52 biases the anchor 17 towards an expanded state. Inflation of the balloon 60 provides additional bulk to occupy volume in the stomach and hence reduce the func tional gastric volume, and to provide an atraumatic lip around the mouth to the tube 12. In Fig. 13, the self-expanding structure 52 comprises a plurali ty of ribs or fingers 56 that bias the anchor towards an expand ed state. Subsequent inflation of the balloon completes or fills-in the tulip shape form around a central evacuation chan nel, to reduce the functional gastric volume, while keeping open a central evacuation channel for entry of chime into the duode nal tube 12.

In Figs. 14 and 15, the self-expanding structure 52 provided ra dially inwardly of the balloon 60, to buttress the tube 12 against the inflation pressure of the balloon 60. This can re inforce the tube 12, so that inflation pressure of the surround ing balloon 60 does not crush or collapse the tube 12, avoiding risk of blockage. However, the combination of the self expanding structure 52 and the balloon 60 permits gastric con tractions of the stomach to be transmitted to the tube 12, to advance chime into and along the tube 12 for evacuation towards the duodenum. The balloon 62 may be partly inflated, e.g. filled to less than full capacity, to facilitate transmission of the gastric contractions to the self-expandable structure 52, and to provide flexibility and conformability to the balloon 60.

The self-expanding structure 52 may be generally coextensive with the balloon 60, at least towards the proximal end of the device. The self-expanding structure 52 may comprise a tubular stent-like structure, for example a braid or lattice structure, made of shape-memory metal, for example, nitinol. In some forms, the axial length of the self-expanding structure may be between about 50mm and 100mm, for example about 80mm. The diam eter of the self-expanding structure 52 may be about 30mm along a majority of its length, optionally with a flared mouth at its proximal end. Figs. 16a to 16g illustrate a technique for introduction and de ployment of the device of Figs. 14 and 15. Referring to Fig. 16a, the device 10 is compressed to a small size and loaded into a delivery system 70 having a sheath 72 for retaining the device 10 radially compressed. The delivery system 70 is introduced through the patient's mouth and into the stomach over a guide- wire 74 placed along the gastrointestinal tract. An imaging sensor 76 may optionally provide guidance to the medical practi tioner.

Referring to Fig. 16b, the delivery system 70 is advanced through the pylorus and into the duodenum, until a radio-opaque marker 78 (either on the tube 12 or on the delivery system 70) becomes aligned with the position of the pylorus.

Referring to Figs. 16c and d, retraction of the sheath 72 de ploys the duodenal tube 12 progressively from the distal end, allowing the self-expanding structures of the first anchor 14 and the second anchor 17 to expand on either side of the pylo rus. Referring to Fig. 16e, complete retraction of the sheath 72 also reveals the balloon 60 which, initially, is uninflated. Referring to Fig. 16f, the balloon 60 is inflated to its opera tive size by means of an inflation line 79 of the delivery sys tem 70 coupled to an inflation port 80 of the balloon 60. Re ferring to Fig. 16g, after inflation, the inflation line 78 is disconnected from the port 80, and the delivery system 70 then removed, leaving the device 10 in situ.

Fig. 17 illustrates a further embodiment in which the second an chor 17 comprises one or more balloons defining plural inflata ble bodies 60. In the illustrated form, the bodies 60 are formed by separate balloons, although in other embodiments, the bodies 60 may be implemented as respective chambers of the same balloon structure. The bodies 60 may be independently inflata ble, or the bodies 60 may be in fluid communication with one an other. The bodies 60 may have one of more shapes selected from elongate and/or spherical, and/or tear-drop, and/or any other desired form. The bodies 60 may nestle together to define col lectively a voluminous bulb, e.g. with a tulip shape, but with a fluted or lobed exterior profile presenting a smaller tissue contacting extremity than would a smooth bulbous single body.

The spaces between and around adjacent bodies also help to keep open natural passages to allow chyme to enter the duodenal tube, and avoid trapping of chyme outside the duodenal tube and bod ies.

Optionally, the second anchor 17 further comprises a self- expandable structure 52. The self-expandable structure 52 may at least partially overlap the bodies 60, or the self-expandable structure may be shorter, such that any overlap is minor.

In all of the embodiments described herein, and whether or not illustrated in the drawings, the duodenal tube 12 may optionally comprise reinforcement 82 (e.g. Figs. 10 and 17) for resisting any tendency of the duodenal tube to twist, at least in one or more local regions. Twisting of the tube can create kinks that might narrow the tube and, in extreme cases, completely block the tube itself to all passage of stomach contents through the twisted region. In one variant, reinforcement 82 of the duodenal tube 12 may be provided between the first and second anchors 14 and 17. The reinforcement 82 may, for example, comprise struc ture, struts or filaments in or on the tube, optionally extend ing from one or both anchors 14 and 17. Additionally or alter natively, reinforcement may be provided in a portion of the tube 12 that is distal to the first anchor 14, as illustrated in Fig. 17. The reinforcement 82 may again comprise structure, struts or filaments in or on the tube 12, optionally extending in a spiral along an axis of the tube 12. In either case, some of the structure, struts or filaments may extend in a direction that is at least partly axial, to buttress the tube against twisting. The structure, struts or filaments may be of metal, for example, nitinol or stainless steel, or of plastics, for ex ample, PET or polyurethane or polytetrafluorethylene.

A further aspect of the embodiments described herein is the pro vision of at least one sensor 90 for sensing a characteristic useful for monitoring the status, shape or size of the device 10, or information about nutrients passing (e.g. passing through) the device 10. In one form, the sensor 90 may option ally monitor the status, shape or size of one or both of the an chors 14 and 17. Referring to Figs. 16 and 17, one such sensor 90 may be a pressure sensor for measuring inflation pressure of the balloon or body 60 and/or the pressure changes transmitted through the balloon by stomach contractions. Additionally or alternatively, the sensor 90 (Fig. 17) may be sensor for sensing a parameter of the chyme passing through the tube 12, such as the flow rate.

Referring to Fig. 18, a communications interface (not shown) permits the sensed information to be communicated to an external receiver and/or monitor 92, for example, a portable device such as a wrist-worn or hand-held electronic device. By way of exam ple, the external device may be a smart-watch or a dedicated wrist-worn electronic bracelet 92. Transmission of data between the device 10 and an external monitor 92 may be via any wired or wireless communication path, such as a near-field communication technique that also enables power to be transmitted to the sen sor 90, for example, by means of an inductive coupling or a ra- dio-frequency communication coupling when the external device 92 is brought into proximity with the device 10 or its sensor 90. The communication interface may optionally be incorporated into the sensor 90 as an integrated module. The wrist-worn device 92 may further have skin-contacting sensors for measuring one or more of: blood pressure and/or blood pulse and/or blood glucose level and/or blood oxygen saturation.

Optionally, the monitoring device 92, or a partner device, such as the patient's smart-phone 92a, may include a software appli cation for storing the information received from the sensor 90 over time, to enable the information to be transmitted to a med ical practitioner's system via wired or wireless communication (for example, to the medical practitioner's smart-phone 92b) for monitoring the performance of the device 10 after installation in the patient. In the case of a device 10 intended for weight- loss, the smart-device may also receive information from weigh ing-scales 94 by which the patient may monitor his or her weight, and optionally body mass index, on a regular basis. In the case of a device 10 intended for treating diabetes, the smart-device 92/92a/92b may also receive information from a glu cose monitor, such a skin-worn device (e.g. 92) or an electronic patch.

Claims

1. A device (10;30) for treatment of obesity or diabetes of a patient, comprising a duodenal tube (12;32), adapted to be placed in the duodenum (D) and optionally jejunum (J) or ileum of a patient, wherein a first anchor (14;34) is arranged at a predefined distance (d) from a proximal (15;35) end of the duodenal tube (12;32), adapted for anchoring the tube (12;32) dis- tally to the pylorus (P), preferably without substantial mucosal involvement.

2. A device according to claim 1, wherein the first anchor (34) comprises an expandable structure (36), in particular a self-expandable structure and/or a balloon expandable structure.

3. A device according to claim 2, wherein the expandable struc ture (36) is made of a metal, preferably a shape memory metal, in particular Nitinol.

4. A device according to claim 3, wherein the self-expandable structure (36) is braided.

5. A device according to one of the claims 2 to 4, wherein the expandable (36) structure is covered by at least one layer of material, in particular a polymeric layer including or made of Dacron or polyurethane or a biologic layer, such as pericardial tissue.

6. A device according to one of the claims 1 to 5, where the first anchor and in particular the first expandable struc ture is retrievable and/or repositionable.

7. A device according to one of the claims 1 to 6, wherein the first anchor comprises patches attachable to the mucosa and linked to the duodenal tube via connectors, the patch pref erably comprising a biocompatible adhesive and preferably being adapted to promote cell biocolonization.

8. A device according to one of the claim 1 to 7, wherein the duodenal tube (12;32) is provided with a second anchor

(17;37) at its proximal end (15; 35), adapted to be posi tioned proximally of the pylorus (P) for anchoring the de vice in the stomach without substantial mucosal involve ment.

9. A device according to claim 8 wherein the second anchor (17) is formed as an inflatable balloon (18), adapted to be po sitioned within the patient's stomach such as to reduce the gastric functional volume and shaped such as to avoid a tight contact with the inner wall of the stomach.

10. A device according to any of claims 1 to 7, wherein the duo denal tube (12;32) is provided with a second anchor coupled to its proximal end (15;35), adapted to be positioned prox imally of the pylorus (P) for anchoring the device in the stomach.

11. A device according to claim 10, wherein the second anchor comprises at least one balloon (17; 60).

12. A device according to claim 9 or 11, wherein the balloon

(18) has an annular shape surrounding the duodenal tube.

13. A device according to claim 12, wherein the balloon (18) has a crown shape.

14. A device according to one of claims 9, 11, 12 or 13, where in the balloon (18) has a toroidal shape.

15. A device according to one of the claims 9 or 11 to 14, wherein the balloon (18) has, optionally in the inflated condition, in an area neighbouring the connection to the duodenal tube (12), a conical outer shape or a concave out er shape in a cross-section through a plane running through an axis of the device.

16. A device according to claim 9 or 11 to 15, wherein the bal loon has a tulip shape in the area neighbouring the connec tion to the duodenal tube.

17. A device according to one of the claims 9 or 11 to 16, wherein the balloon (18) is adapted to be inflated to a volume of 200 ml to 800 ml, preferably 300 to 450 ml.

18. A device according to any of claims 8 to 17 wherein the se cond anchor (37) comprises or further comprises a second expandable structure (38), in particular a self-expandable structure or a balloon expandable structure.

19. A device according to any of claims 8to 18, wherein the se cond anchor has an at least partly hour-glass shape.

20. A device according to claim 18 or 19, wherein the second ex pandable structure (38) is made of a metal, preferably a shape memory metal, in particular Nitinol.

21. A device according to any of claims 18 to 20, wherein the second expandable structure (38) is braided.

22. A device according to any of claims 18 to 21, wherein the second expandable structure (38) is covered by at least one layer of material, in particular a polymeric layer includ ing or made of Dacron or a biologic layer, such as pericar dial tissue.

23. A device according to any of claims 1 to 22, wherein the de vice is provided with at least one additional element (19; 39a, 39b) on the duodenal tube, in particular a metallic element and/or a radiopaque element.

24. A device according to claim 23, wherein the at least one

(19; 39a, 39b) element is formed as a ring mounted on at least one of a distal end (20;40) of the duodenal tube (12;32) and an area (21;41) distant from the distal end of the duodenal tube, preferably distant by 8 to 12 cm.

25. A device according to any of claims 1 to 24, wherein the du odenal tube (12;32) is adapted to be shortened for adapta tion to at least one characteristic of the patient.

26. A device according to any of claims 1 to 25, wherein at least one of the duodenal tube, the first anchor and the second anchor is activatable by contact with contents of the intestine and/or stomach.

27. A device according to any of claims 1 to 26, wherein the first anchor has an axial length of 1 cm to 10cm, optional ly 1 cm to 3 cm.

28. A device according to any of claims 8 to 27, wherein the se cond anchor (17;37) has an axial length of 2 cm to 10 cm.

29. A device according to one of the claims 1 to 28, wherein the duodenal tube (12;32) is made of a material which reduces a contact of nutrients migrating within the tube with the du odenal wall, in particular made of polyurethane.

30. A device according to one of the claims 1 to 29, wherein the duodenal tube (12;32) has a length in the range of 300 mm to 800 mm, in particular about 600 mm and/or a diameter of 25 to 35 mm, in particular about 28 mm.

31. A device according to claim 9 or 11, or any claim dependent thereon, wherein amongst the first anchor and the second anchor, only one of said anchors comprises a combination of a self-expandable structure coupled to the balloon.

32. A device for treating diabetes or obesity, optionally as de fined in any preceding claim, the device comprising a por tion installable within the gastro-intestinal tract of a patient, optionally in the duodenum and/or the stomach, the device comprising at least one sensor which provide infor mation relating to one or more of: (i) the status of at least a portion of the device; (ii) the shape of at least a portion of the device; (iii) the size of at least a portion of the device; (iv) nutrients passing the device, for exam ple, passing within the device.

33. A device according to claim 32, wherein the sensor is con figured for transmitting the information externally of the device via wireless communication.

34. A device according to claim 32 or 33, wherein the device comprises a balloon, and the sensor is a pressure sensor for sensing balloon pressure.

35. A method for selecting a device for treatment of obesity or diabetes of a patient, in particular a device (10;30) ac- cording to one of the claim 1 to 31, comprising the steps of

- determining at least one characteristic of the patient select ed from the group of thickness of the abdominal fat pani cle, fat mass surrounding the abdominal cavity, visceral fat mass, the fat inside and/or outside the abdominal cavi ty, body surface area, Body Mass Index and abdominal perim eter, elasticity of the stomach, index of elasticity of the stomach, index of absorption for nutrients, measured on standing patient, at the umbilicus

- defining a length of a duodenal tube (12;32) on the basis of the selected characteristic

- providing a device (10;30) with a duodenal tube (12;32) having the defined length by one of (i) shortening the duodenal tube (12;32) to the defined length or (ii) selecting a de vice having a duodenal tube (12;32) with the defined length.

36. A method according to claim 35, comprising the further step of defining a filling volume of a gastric anchoring balloon based on the determined characteristic.

37. A method according to claim 35 or 36, wherein the fat inside and/or outside the abdominal cavity is determined by Com puterized Tomodensitometry.